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REGENXBIO: dữ liệu topline pivotal của RGX-202 dự kiến vào đầu Q2 2026

The company announced that pivotal topline results from the confirmatory Phase I/II AFFINITY DUCHENNE trial of RGX-202 are expected in early Q2 2026. Enrollment in the confirmatory trial (n=30) is ongoing and the majority of patients are expected to be enrolled by the time of the planned BLA submission.

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Nộp lúc
12:30 5 thg 3, 2026
Sự kiện
Kết quả topline
Chiều hướng
Trung lập
Công ty
RGNXREGENXBIO
Tài sản
RGX-202
Nguồn
SEC 8-K
Độ tin cậy
Có nguồn

Trích đoạn nguồn

EX-99.1 2 rgnx-ex99_1.htm EX-99.1 EX-99.1 EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights • Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts o RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026 - Robust patient enrollment continues in confirmatory trial o Surabgene lomparvovec (sura-vec, ABBV-RGX-314) subretinal wet AMD topline pivotal data expected in Q4 2026; first patient dosed in pivotal Phase IIb/III trial in diabetic retinopathy expected in Q2 2026 • Company to engage FDA on potential path forward for RGX-121 • Conference call today at 8:00 a.m. ET ROCKVILLE, Md., March 5, 2026 (PR Newswire) -- REGENXBIO

SEC 8-K

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